WHAT THE F.D.A. ISN'T TELLING: PATIENT DEATHS IN DRUG TESTS

[TOOLZ]

Drug Secrets
What the FDA isn't telling.
By Jeanne Lenzer


Traci Johnson's body was discovered on Feb. 7, 2004, hanging by a scarf from a shower rod in an Indianapolis laboratory run by the drug company Eli Lilly. The 19-year-old college student had been serving as a test subject in a clinical trial of the experimental antidepressant duloxetine. Investigators from the Food and Drug Administration rushed to Indianapolis to determine whether the experimental drug was related to her death. The probe was inconclusive.

This left researchers in a quandary: Was the drug safe or not? Could duloxetine trigger suicide, as some experts suggested? Or was Johnson's death an "isolated tragedy," as Eli Lilly claimed? When drug manufacturers fail to publish negative study results, as studies show is often the case, the best source of information about these questions is the FDA. The agency—which was rocked last week by the sudden resignation of Commissioner Lester Crawford—requires companies seeking approval for a drug to provide data from randomized controlled trials, studies in which some patients are given the drug and others are given a placebo. But when researchers and the press started asking about duloxetine, the FDA didn't scour its database and go public. It kept quiet.

The FDA gave a legal rationale for its silence: Some clinical trial data are considered "trade secrets," or commercially protected information, and thus are exempted from release under the Freedom of Information Act.

<http://www.slate.com/id/2126918/#ContinueArticle>

[walkon]

1. Trade Secret =

Number of patient deaths caused by "treatment".

Commercially protected information = FDA role in keeping trade secrets secret

[The Backlash Cometh]

2. Once it gets into the Supreme Court, nothing overrides public interest.

[elehhhhna]

3. That's an abuse of Trade Secret law if ever there was one:

Here's the legal definition-- the intent of the rule is NOT that one can hide the deadly aspects of one's product:

"Patent, Trademark, and Trade Secret Law

TRADE SECRET LAW
A trade secret is information of any sort that is valuable to its owner, not generally known, and that has been kept secret by the owner. Trade secrets are protected only under state law. The Uniform Trade Secrets Act, in effect in a number of states, defines trade secrets as "information, including a formula, pattern, compilation, program, device, method, technique, or process that derives independent economic value from not being generally known and not being readily ascertainable and is subject to reasonable efforts to maintain secrecy."

Types of Works Protected
The following types of technical and business information are examples of material that can be protected by trade secret law:

Customer lists.
Designs.
Instructional methods.
Manufacturing processes.
Document-tracking processes.
Formulas for producing products.
Inventions and processes that are not patentable can be protected under trade secret law. Patent applicants generally rely on trade secret law to protect their inventions while the patent applications are pending.


Standards
Six factors are generally used to determine whether material is a trade secret:

The extent to which the information is known outside the claimant's business.
The extent to which the information is known by the claimant's employees.
The extent of measures taken by the claimant to guard the secrecy of the information.
The value of the information to the claimant and the claimant's competitors.
The amount of effort or money expended by the claimant in developing the information.
The ease with which the information could be acquired by others.
Information has value if it gives rise to actual or potential commercial advantage for the owner of the information. Although a trade secret need not be unique in the patent law sense, information that is generally known is not protected under trade secrets law.

http://profs.lp.findlaw.com/patents/patents_3.html

[whatever4]

4. Figures

It just figures. After being prescribed 300 mg of Effexor for over two years, and having numerous seemingly unrelated new health problems which I tied to the med (not the doctor, she was clueless, but after I stopped taking everything else, there was nothing left to blame) I was moved to Cymbalta, discussed in this article.

"The FDA approved Cymbalta to treat depression in August 2004." So it was just a few months after they released it that that braniac prescribed it to ME, oh lucky me, test subject unwilling. And I changed off of Effexor due to side effects.

Then there's my dad that took Vioox (spelling, sorry) for about 6 months. And his health wasn't the best to start with either.

I just can't believe this nation, and it's doctors, and the entire system of medicine. GODS. And people wonder why I want cannabis legal...I swear, I'm the only sane one sometimes, and it truly isn't my fault. 's really not. Medicine people could afford that wouldn't kill them, or even make them want to kill themselves. NO...that's just crazy talk...and they'll kill us for it, one way or another.

[tkmorris]

5. OK boys and girls, let's play "What if"?

Let's imagine shall we that a lawsuit is brought against the FDA and Eli Lilly alleging that they are liable for damages from deaths due to a drug they approved while witholding from the public information from clinical trials wherein testees became depressed or committed suicide. Let's call this drug "duloxetine".

All legal arguments aside, how do you imagine our good friend and Chief Justice nominee John Roberts would rule on the case? Would he agree that virtually any information the drug companies wanted kept secret would qualify as a "trade secret"?

You bet your sweet ass he would.

[Lindacooks]

6. The illness, depression, has a 10% suicide rate.

Some people don't respond well, or at all, to meds. Depression patients killing themselves is not at all uncommon, which is why they MUST be closely monitored, especially when trying new meds.

And meds DO work. I'm living proof, and so are many in my family.

[Wordie]

7. Do you have a link to that stat?

What percentage of suicides WERE taking their meds? Did they control for medication, in other words in the study that produced the statistic you quoted?

I know some put a lot of faith in them, but if 10% of people get WORSE, to the point of potential suicide, that is a BIG problem, imho. Of course, I'm making an assumption there, but then, so frequently do the interpreters of studies, or the sponsors of them (the drug companies). We need further oversight of these studies. The FDA MUST require that the results and study methodologies are open to scrutiny. There surely are ways to do that without exposing trade secrets.

[Lindacooks]

8. Here you go:

http://www.add-adhd-help-center.com/Depression/statistics.htm

It turns out women with severe depression commit suicide at about a 15% rate.

And I've seen the 10% figure on many billboards advocating people get help for the disease.

And of course I believe that these studies need to be transparent, peer reviewed, and duplicated before drugs are put on the market. What I'm concerned about is someone reading this will think that it's perfectly fine to just try to live with depression and not get help for it. It's a genuine physical illness, with treatment, and with consequences.

There's also this study from UCLA:

http://newsroom.ucla.edu/page.asp?RelNum=5880

Challenging recent claims linking antidepressant use to suicidal behavior, a new UCLA study shows that American suicide rates have dropped steadily since the introduction of Prozac and other serotonin reuptake inhibitor (SSRI) drugs. In research published Feb. 1 in the journal Nature Reviews Drug Discovery, the authors caution that regulatory actions to limit SSRI prescriptions may actually increase death rates from untreated depression, the No. 1 cause of suicide.

"The recent debate has focused solely on a possible link between antidepressant use and suicide risk without examining the question within a broader historical and medical context," said Dr. Julio Licinio, a professor of psychiatry and endocrinology at the David Geffen School of Medicine and a researcher at the UCLA Neuropsychiatric Institute. "We feared that the absence of treatment may prove more harmful to depressed individuals than the effects of the drugs themselves."

"The vast majority of people who commit suicide suffer from untreated depression," he said. "We wanted to explore a possible SSRI-suicide link while ensuring that effective treatment and drug development for depression were not halted without cause."

Emphasis mine.

[Wordie]

10. The first link you provided really wasn't to any research data supporting

the statement that 10% of people who experience depression commit suicide. The first link took me to a site advertising medications.

And the second statement was a statement of opinion by a doctor. I still didn't see any research data.

Edited to add: I have now followed the second link, and stand corrected. The UCLA doctor did quote a study that did imply that the deaths were from untreated depression. Excuse my cynical self. My experience has too often been that numbers are frequently thrown around in this debate that may not have much to back them up. One question though: the study quoted the hospital study, saying,
<snip>
"Researchers found blood antidepressant levels in less than 20 percent of suicide cases," Licinio said. "This implies that the vast majority of suicide victims never received treatment for their depression."

What I wondered is if this is another of those use-the-numbers-to-support-your-position kinda things, because one question that occurs to me is, were autopsies performed on all of the suicides in question? And a related question might be, if they DID find antidepressents in around 20% of suicides, isn't that a rather high number? What does that say about efficacy, really? It may be a question of interpretation, as it so often is with statistics.

I am not trying to be difficult here. I really would like to know if those stats are accurate...and what they truly mean about depression and antidepressants.

[Lindacooks]

11. First of all, the second link was a study, not a doctor's opinion.

And here:

"Thirty percent of all clinically depressed inpatients attempt suicide and about half succeed."

http://www.wga.org/health/depression_suicide.html

As I said before, I've seen the number 10% on billboards, and my psych doc confirmed that. If you don't believe it, do the research yourself on Google.

[Wordie]

13. Linda, that last link was to suicide info on the Writer's Guild site.

Here is the whole thing:
<snip>
* Thirty percent of all clinically depressed inpatients attempt suicide and about half succeed. -AFSP 2003

I requoted it because of the reference there, "AFSP." Do you know what those initials stand for? I sure don't. This is what I mean about numbers being thown around in the mental health field, rather indiscriminately. (And I don't mean you, here, I mean by other well-meaning people, such as whoever did the Writer's Guild page.) The problem is that these numbers often do more to confuse the issue, rather than add to our knowledge, when the sources are unclear.

Maybe all those numbers are accurate, maybe they aren't.

Please don't take this personally. If antidepressants work for YOU, great! I only object to those who make use of "meds" a crusade, and assume that everyone should be like them. And, by doing so, take all focus (and funding) away from anyone who might want to explore some other treatment avenue.

Edited for punctuation.

[Kailassa]

9. druggies ;-)

You and me both, Lindacooks, I'm a prozac-popper, and not by choice, clinical depression is a serious illness that needs treatment. However I wonder how much the stress and barrage of chemicals in our everyday environment is responsible for the problem.

The problem with drug companies is that they can only test things they can patent, so natural rememdies can never be adequately tested; there is no money in paying to test something that everybody can sell. So all the old knowlege of natural remedies, instead of being refined and developed, is swept away by the deluge of drugs the doctors are encouraged to push.

So those of us needing medical help often have to make a decision on how much harm we are going to risk for the help we hope a drug will give.

[Lindacooks]

12. I would feel better about natural remedies if there were peer reviewed

double blind studies conducted on them too. One of the problems with 'natural cures' and the health food industry is that there is absolutely no government regulation at all. In fact, Consumer Reports did a study where they tested the content of 'active ingredients' that were supposed to be in natural remedies. Often, there was NO ONE GRAIN of that ingredient in the pill or powder. And often there are ingredients in those potions not listed on the label, sometimes in harmful amounts.